Compares two pre-surgery treatments for older people with locally advanced rectal cancer
Compares two standard pre-surgery treatments in people aged 70 or older with rectal cancer.
Plain-language title generated from the registry record
Registry title: Efficacy and Safety of Conventional Neoadjuvant Therapy Versus Total Neoadjuvant Therapy in Older Patients With Locally Advanced Rectal Cancer
Key facts
- Where
- Anderlecht, Antwerp, Auderghem, Brussels, Charleroi, Edegem, Ghent, Godinne, Haine-Saint-Paul, Hornu, Libramont, Liège, Mons, Namur, Sint-Niklaas, and Turnhout, BelgiumSee the 19 sites
Where in Belgium
- Institut Jules BordetAnderlecht, BelgiumTaking people
- ZAS AntwerpenAntwerp, BelgiumTaking people
- Chirec DeltaAuderghem, BelgiumTaking people
- CHU BrugmannBrussels, BelgiumTaking people
- CHU Saint-PierreBrussels, BelgiumTaking people
- CHU CharleroiCharleroi, BelgiumNot yet recruiting
- Grand Hopital de CharleroiCharleroi, BelgiumNo longer taking part
- UZA- AntwerpenEdegem, BelgiumTaking people
- UZ GentGhent, BelgiumTaking people
- CHU UCL NamurGodinne, BelgiumTaking people
- Hôpital de JolimontHaine-Saint-Paul, BelgiumTaking people
- EpicuraHornu, BelgiumTaking people
- CHA LibramontLibramont, BelgiumTaking people
- CHU de Liège (Sart Tilman)Liège, BelgiumTaking people
- CHU Ambroise ParéMons, BelgiumNot yet recruiting
- CHR Sambre et Meuse (site Meuse)Namur, BelgiumNot yet recruiting
- CHU St ElisabethNamur, BelgiumTaking people
- AZ NikolaasSint-Niklaas, BelgiumTaking people
- AZ TurnhoutTurnhout, BelgiumTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Jules Bordet Institute
- Trial code
- NCT06052332
- Record updated
- 3 August 2026
- Original description
The SHAPERS study is a multicentre, open-label, randomised, pragmatic clinical trial, comparing standard-of-care neoadjuvant treatment options for older (i.e., ≥70 years) subjects with high-risk stage II and stage III rectal cancer.Read full original descriptionShow less
Efficacy and Safety of Conventional Neoadjuvant Therapy Versus Total Neoadjuvant Therapy in Older Patients With Locally Advanced Rectal Cancer: a Multicentre, Open-label, Randomised Pragmatic Clinical Trial
The SHAPERS study is a multicentre, open-label, randomised, pragmatic clinical trial, comparing standard-of-care neoadjuvant treatment options for older (i.e., ≥70 years) subjects with high-risk stage II and stage III rectal cancer.
Inclusion: Age ≥ 70 years old; ECOG performance status (PS):; ≤1 if age > 75 years old; ≤2 if age ≤ 75 years old; Histologically or cytologically confirmed adenocarcinoma of the rectum; Distal border of the tumour below the peritoneal reflection and within 15 cm of the anal verge; Operable stage III or high-risk stage II rectal cancer (high-risk tumours defined as those having ≥1 of the following features: T4, mesorectal fascia (MRF) involvement/threatening [i.e.,tumour within 1 mm of the MRF], extramural venous invasion). Patient with involvement of lateral pelvic lymph nodes are also eligible; Adequate bone marrow function as defined below:; Absolute neutrophil count ≥1,500/µL; Haemoglobin ≥9 g/dL; Platelets ≥100,000/µL; Adequate liver function as defined below:; Serum total bilirubin ≤1.5 x ULN. In case of known Gilbert's syndrome <3xUNL is allowed; AST (SGOT) and ALT (SGPT) ≤2.5 x ULN; Alkaline phosphatase ≤2.5 x ULN; Adequate renal function as defined by estimated glomerular filtration rate (GFR) ≥30 mL/min/1.73m² (according to the CKD-EPI 2021 equation); Absence of clinical conditions that in the opinion of the investigator, would contraindicate neoadjuvant therapy and/or surgery; Signed Informed Consent form (ICF) obtained prior to any study related procedure; Male subjects with partners of childbearing potential must agree to use condom during the course of this study and for at least 6 months after the last administration of study drugs.
Exclusion: Extensive growth into cranial part of the sacrum (above S2/3 junction) or the lumbosacral nerve roots indicating that surgery will never be possible even if substantial tumour down-sizing is achieved; Any contraindication to pelvic irradiation as evaluated by the investigator; Known hypersensitivity reactions to the study drugs or to any excipients, premedications or non-investigational medicinal products or concomitant medications; Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment; Any previous treatment for rectal cancer; Presence of metastatic disease or recurrent rectal tumour; Significant medical, neuro-psychiatric, or surgical condition, currently uncontrolled by treatment, which, in the principal investigator's opinion, may interfere with completion of the study; Any investigational anti-cancer therapy other than the protocol specified therapies (participation in other prospective studies which do not imply any specific intervention may be allowed after discussion with the Study Chair); Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke, myocardial infarction, unstable angina, congestive heart failure (grade III or IV as classified by the New York Heart Association), or serious cardiac arrhythmia requiring medication within the past 6 months; Presence of grade ≥2 peripheral neuropathy according to the Common Toxicity Criteria for Adverse Events (CTCAE) v.5.0; Complete dihydropyrimidine dehydrogenase (DPD) deficiency; Use of brivudine, sorivudine or their chemically related analogues.